This device is not distributed in us so that 510k# is blank.The product was returned to pentax medical for repair.Our technician checked the returned unit and confirmed that the cfb (coherent fiber bundle) fluid damage.Based on the result, we concluded that it was caused due to the fluid damage from the cfb (coherent fiber bundle).In addition, our technician confirmed that the bending rubber perforated, and the insertion flexible tube buckled; however, these defects are not the main cause, and/or irrelevant to the alleged complaint.Based on the technical report and/or the risk analysis results, it was evaluated to submit mdr.
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